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BrosMed Medical Co.,Ltd. recalls Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac
Recalled March 6, 2019 · FDA recall Z-0963-2019 · BrosMed Medical Co.,Ltd
Hazard
Incorrect (higher) Rated Burst Pressure information printed on label. · FDA Class II
Units
400
Sold at
US Distribution to MO.
Description
Incorrect (higher) Rated Burst Pressure information printed on label.
Product
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
Manufacturer(s)
BrosMed Medical Co.,Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →